Microbiome and Association With Implant Infections

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT05020574
Phase
PHASE2
Status
Recruiting
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Conditions

  • Breast Cancer
  • Breast Cancer Female
  • Genetic Predisposition to Disease

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cephalexin — DRUG
    Given orally (PO)

Study Details

The most common tissue expander-related infections are from Staphylococcus and Pseudomonas species. In addition, from breast tissue microbiome studies, Staphylococcus and Pseudomonas show variable abundance across samples. The investigator hypothesizes that participants undergoing mastectomy with high initial abundance of Staphylococcus and/or Pseudomonas are more likely to develop subsequent tissue expander-related infections from these respective organisms.

Key Dates

Start date
Sep 28, 2021
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Cohort A: Standard antibiotics
    Receive standard pre-incision antibiotics and 24-hour perioperative antibiotics - Prescribed standard postoperative antibiotics to take for at least 7 days post-operatively
  • No Intervention: Cohort B: No antibiotics
    Receive standard pre-incision antibiotics and 24-hour perioperative antibiotics - No antibiotics post-operatively, unless patient develops clinical evidence of infection

Primary Outcome Measure

Proportion of tissue samples obtained successfully over time [ Time Frame: 90 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Laura Barnes, MD
[email protected]
415-502-1259
[email protected]
877-827-3222
Merisa Piper, MD (PRINCIPAL_INVESTIGATOR)
Laura Barnes, MD (SUB_INVESTIGATOR)
Michael Campbell, PhD (SUB_INVESTIGATOR)

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